SAMURAI-NVAF Study: Anticoagulant Therapy for Japanese Stroke Patients With Nonvalvular Atrial Fibrillation (NVAF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by Ministry of Health, Labour and Welfare, Japan
Sponsor:
Information provided by (Responsible Party):
Kazunori Toyoda, Ministry of Health, Labour and Welfare, Japan
ClinicalTrials.gov Identifier:
NCT01581502
First received: April 16, 2012
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to determine choice of anticoagulant therapy during acute and chronic stages of ischemic stroke/TIA and short- and long-term outcomes, including stroke recurrence and bleeding complications, in patients having nonvalvular atrial fibrillation.


Condition Intervention
Stroke, Acute
Atrial Fibrillation
Other: This is an observational study.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Stroke Acute Management With Urgent Risk-factor Assessment and Improvement (SAMURAI) Study on Anticoagulant Therapy in Nonvalvular Atrial Fibrillation (NVAF)

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Labour and Welfare, Japan:

Primary Outcome Measures:
  • Ischemic events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Recurrence of ischemic stroke/TIA, ACS, systemic embolism, aortic dissection, rupture of aortic aneurysm, peripheral artery disease (required hospitalization), VTE, revascularization (including CEA/CAS, PCI, etc)

  • major bleeding [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Major bleeding according to the ISTH definition, including fatal bleeding, intracranial hemorrhage, etc


Secondary Outcome Measures:
  • modified Rankin Scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    modified Rankin Scale

  • Modification of anticoagulant medication [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: September 2011
Estimated Study Completion Date: December 2015
Groups/Cohorts Assigned Interventions
NVAF, acute ischemic stroke/TIA
Consecutive acute ischemic stroke/TIA patients with nonvalvular atrial fibrillation; most of these patients begin to receive anticoagulant therapy after index stroke/TIA for secondary prevention
Other: This is an observational study.
This is an observational, not intervention, study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

inpatients

Criteria

Inclusion Criteria:

  • Consecutive acute ischemic stroke/TIA patients with NVAF

Exclusion Criteria:

  1. Rheumatic mitral valve disease
  2. A history of prosthetic valve replacement or mitral valve surgical repair
  3. Active infective endocarditis
  4. Patient, family member or legally responsible person does not have given informed consent
  5. Inappropriate patient's conditions for study enrollment in the opinion of the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581502

Contacts
Contact: Shoji Arihiro, MD sarihiro@hsp.ncvc.go.jp

Locations
Japan
National Hospital Organization Nagoya Medical Center Recruiting
Nagoya, Aichi, Japan
Contact: Satoshi Okuda, MD         
Principal Investigator: Satoshi Okuda, MD         
Toyota Memorial Hospital Recruiting
Toyota, Aichi, Japan
Contact: Yasuhiro Itoh, MD         
Principal Investigator: Yasuhiro Itoh, MD         
Brain Attack Center Ota Memorial Hospital Recruiting
Fukuyama, Hiroshima, Japan
Contact: Kazuhiro Takamatsu, MD         
Principal Investigator: Kazuhiro Takamatsu, MD         
Nakamura Memorial Hospital Recruiting
Sapporo, Hokkaido, Japan
Contact: Jyoji Nakagawara, MD         
Principal Investigator: Jyoji Nakagawara, MD         
Kobe City Medical Center General Hospital Recruiting
Kobe, Hyogo, Japan
Contact: Kenichi Todo, MD         
Principal Investigator: Kenichi Todo, MD         
St Marianna University School of Medicine Recruiting
Kawasaki, Kanagawa, Japan
Contact: Yasuhiro Hasegawa, MD         
Principal Investigator: Yasuhiro Hasegawa, MD         
South Miyagi Medical Center Recruiting
Ogawara, Miyagi, Japan
Contact: Hiroshi Mochizuki, MD         
Principal Investigator: Hiroshi Mochizuki, MD         
Kohnan Hospital Recruiting
Sendai, Miyagi, Japan
Contact: Eisuke Furui, MD         
Principal Investigator: Eisuke Furui, MD         
Kawasaki Medical School Recruiting
Kurashiki, Okayama, Japan
Contact: Kazumi Kimura, MD         
Principal Investigator: Kazumi Kimura, MD         
National Cerebral and Cardiovascular Center Recruiting
Suita, Osaka, Japan, 565-8565
Principal Investigator: Kazunori Toyoda, MD         
Sub-Investigator: Hiroshi Yamagami, MD         
Sub-Investigator: Masatoshi Koga, MD         
Jichi Medical University School of Medicine Recruiting
Shimotsuke, Tochigi, Japan
Contact: Kazuomi Kario, MD         
Principal Investigator: Kazuomi Kario, MD         
Kyorin University School of Medicine Recruiting
Mitaka, Tokyo, Japan
Contact: Yshiaki Shiokawa, MD         
Principal Investigator: Yshiaki Shiokawa, MD         
National Hospital Organization Kyushu Medical Center Recruiting
Fukuoka, Japan
Contact: Yasushi Okada, MD         
Principal Investigator: Yasushi Okada, MD         
National Hospital Organization Kagoshima Medical Center Recruiting
Kagoshima, Japan
Contact: Takahiro Nakashima, MD         
Principal Investigator: Takahiro Nakashima, MD         
Japanese Red Cross Kumamoto Hospital Recruiting
Kumamoto, Japan
Contact: Tadashi Terasaki, MD         
Principal Investigator: Tadashi Terasaki, MD         
Japanese Red Cross Kyoto Daini Hospital Recruiting
Kyoto, Japan
Contact: Yoshinari Nagakane, MD         
Principal Investigator: Yoshinari Nagakane, MD         
Sponsors and Collaborators
Ministry of Health, Labour and Welfare, Japan
Investigators
Principal Investigator: Kazunori Toyoda, MD SAMURAI Study Investigators
  More Information

Additional Information:
No publications provided

Responsible Party: Kazunori Toyoda, National Cerebral and Cardiovascular Center, Ministry of Health, Labour and Welfare, Japan
ClinicalTrials.gov Identifier: NCT01581502     History of Changes
Other Study ID Numbers: samurai2011, samurai nvaf 2011
Study First Received: April 16, 2012
Last Updated: April 18, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ministry of Health, Labour and Welfare, Japan:
Anticoagulation
Recurrent stroke
Bleeding

Additional relevant MeSH terms:
Anticoagulants
Atrial Fibrillation
Stroke
Cerebral Infarction
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014